Cdsco Roles and Responsibilities

for mpharm

1. MR. SANDIP N MAVCHI FIRST YEAR M.PHARMACY (QA) SVBCP DOMBIVLI SEMINAR ON CDSCO Guided by Prof.Vaibhav kulkarni sir

2. SEMINAR OUTLINE.. What is CDSCO.? Vision, Mission Values and strategies. Hierarchy of CDSCO. Head office and zonal offices . Functions of CDSCO. Functions of central authority. Functions of State Authority. Functions of Port O ffi ces of CDSCO Joint responsibilities of CDSCO and SLAs. New and investigational drug application and approval process. Three tier review process. Medicl devices and diagnostics. CDSCO- Sugam BA/BE tests application. Clinical trials. CDL and its fuctions . Refrences .

3. What is CDSCO….?? It is the National Drug Regulatory Authority of the Government of India. Central Drugs Standard Control Organization (CDSCO) exercises regulatory control over the quality of drugs, cosmetics and notified medical devices in the country. It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.

4. To Protect and Promote public health in India. To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

5. To achieve the mission and mandate of the CDSCO we will strive to act with Transparency, Accountability, Punctuality, Courtesy, Openness, Responsiveness, Professionalism, Impartiality, Consistency, Integrity And Truthfulness.

6. Strategies Initiate in framing of rules, regulations and guidance documents to match the contemporary issues in compliance with the requirements of Drugs & Cosmetics Act 1940 and Rules 1945. Facilitate in Uniform implementation of the provisions of the Drugs & Cosmetics Act 1940 and Rules 1945.

7. Hierarchy Indian government Ministry of health and family planning and welfare Drugs controller general of India Joint drugs controller (2) Deputy drugs controllers ( 10) Assistant drugs controllers(25) Director administration Deputy director( Adm ) Section officer ( Adm )

8. HEAD OFFICES AND ZONAL OFFICES The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

9. Oversight and market Surveillance through Inspectorate of Centre Over and above the State Authority.

10. 1.Laying down standards of drugs, cosmetics, diagnostics and devices. 2.Laying down regulatory measures, amendments to Acts and Rules. 3.To regulate market authorization of new drugs . 4.To regulate clinical research in India. Functions of central authority

11. 5.To approve licenses to manufacture certain categories of drugs as Central Licence approving Authority i.e. for Blood Banks, Large Volume Parenteral and Vaccines & Sera. 6.To regulate the standards of imported drugs. 7. Testing of drugs by Central Drugs Labs. 8. Publication of Indian Pharmacopoeia.

12. Licensing of drug manufacturing and sales establishments. Licensing of drug testing laboratories. Approval of drug formulations for manufacture. Monitoring the quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state. Functions of State Authority

13. Functions of State Authority Investigation and prosecution in respect of contravention of legal provisions. Administrative actions. Pre- and post- licensing inspection Recall of sub-standard drugs.

14. Scrutiny of bills of entry with a view to ensuring that imported drugs comply with the regulations. To check the shipping bills for export for statistical data and keep control under the regulations To ensure that no New Drug is imported into the country unless its import is permitted by the Drugs Licensing Authority under Rules 122 A & 30-AA. To ensure that small quantities of drugs imported for clinical trials or for personal use are duly permitted under Test License (11 or 11-A) or Permit License as (12 B) as the case may be. Functions of Port O ffi ces of CDSCO

15. Functions of Port O ffi ces of CDSCO Maintenance of Statistics regarding import and export of drugs and cosmetics. Coordination with Customs authorities. Coordination with States Drugs Controllers and Zonal Offices for post-import checks. Preparation of monthly / quarterly / annual reports. To draw samples from import/export and re-import consignments

16.  state licensing authorities

17. New Guidelines were effective from Jan 1, 2018  The Risk based classification for medical devices Class A- Low Risk (Thermometer, Tongue Depressor) Class B- Low Moderate Risk (Suction Equipment, Hypodermic Needle) Class C-High Moderate Risk (Ventilator, Bone Fixation Plate) Class D- High Risk (Heart Valves)

18. CDSCO- Sugam This project has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business. It is the project of national importance that directly reflects the Governments DIGITAL INDIA initiatives. It is a major influence in bringing reforms in the Indian Pharma Industry .

19. FOR BA/BE TESTS APPLICATION The applicants submit the application for BE NOC & Test Licence through online Sugam Portal in applicable checklist. The application will be processed by the Assistant Drugs Inspector/Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for recommendation for approval then DCG(I) (Licensing Authority) will grant the BE NOC & Test Licence to the applicant through Online Sugam Portal.

20. FLOW CHART FOR BA/BE TEST APPLICATION

21. Application forwarded to Reviewing Officer After review forwarded to NO After review forwarded to DDA/DA If any deficiency in documents Q u e r y If all the documents are in Order Forwarded to LA Approval Application received by Nodal Officer Online submission of application with requisite documents Approval process for Post Approval Application received Online Sugam Portal with respect to Global Clinical Trials Division. Applicant

22. Central Drug Testing Laboratories

23. Analytical quality control of majority of the imported Drug available in Indian market. Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations. Preparation of National Reference Standards and maintenance of such Standards. Maintenance of microbial cultures useful in drug analysis Distribution of Standards and cultures to State Quality Control Laboratories and drug manufacturing establishments. Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.

24. Training of World Health Organization Fellows from abroad on modern methods of Drug Analysis. To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting license. To work out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India. To undertake analytical research on standardisation and methodology of Drug and cosmetics.

25. Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organization. Quick analysis of life saving Drug on an All-India basis received under National Survey of Quality of Essential Drug Programme from Zonal Offices of Central Drug Standard Control Organization.

26. References https://www.slideshare.net/viveksachithananthan/cdsco-a-regulatory-overview   http://w ww.jli.edu.in/blog/roles-and-responsibilities-of-cdsco/   http://c dsco.nic.in/writereaddata/Guidance%20documents.pdf   https://www.slideshare.net/bdvfgbdhg/central-drug-standard-control-organisation   http://w ww.cdsco.nic.in/writereaddata/Scan1.pdf   https://cdsco.gov.in/opencms/opencms/en/Home/   https://cdscoonline.gov.in/CDSCO/homepage

27. THANK YOU